510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QSZUnclassified

Absorbable Synthetic Wound Dressing

Unknown
FDA source (opens on fda.gov)

QSZ is the FDA product code for Absorbable Synthetic Wound Dressing. FDA's definition for this code reads: "Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application". As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QSZ
Device name
Absorbable Synthetic Wound Dressing
FDA definition
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
21
Ingested recalls
0

Clearances, product code QSZ

By decision year
21 clearances under product code QSZ with a decision year between 2003 and 2026, 2017 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code QSZ by decision year
YearClearances
20031
20071
20091
20141
20151
20161
20173
20181
20201
20222
20232
20241
20252
20263

Applicants with the most clearances

Product code QSZ
Applicants holding the most 510(k) clearances under product code QSZ
ApplicantClearances
Polynovo Biomaterials Pty Ltd5
Acera Surgical, Inc. C/O Linda Braddon, PhD3
SiOxMed, LLC3
Polymedics Innovations2
Anika Therapeutics, Inc.1
Beijing Kreate Medical Co., Ltd.1
Biomet Merck GmbH1
Engineered Tissue Solutions, LLC1
Fidia Advanced Biopolymers SRL1
Huizhou Foryou Medical Devices Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order